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FDA | FDA Centennial
Food Safety World Conference and Expo
Andrew C. von Eschenbach, M.D.
Acting Commissioner of Food and Drugs
March 9, 2006
This text contains Dr. von Eschenbach's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.
Good morning, and thank you, Martin, for the opportunity to speak with all of you today. I am especially grateful for the opportunity to be here, because this is our first chance to meet each other, to introduce ourselves, and begin an important dialogue — important because you are key stakeholders and partners on the frontlines of food safety and nutrition.
In the 5 months I have been privileged to be Acting Commissioner of the FDA, I have witnessed the value of maintaining strong collaboration and cooperation with our partners in the food safety industry. It is my distinct pleasure to play a role in that ongoing relationship, and to watch it flourish and grow.
I would like to speak with you this morning about some of the issues, actions, and policies that affect all of us and which, more importantly, protect the American consumers we ultimately serve.
Food Safety/Defense
Maintaining the safety and security of our global food supply is the responsibility of everyone in this room: the industry, as well as local, state, and national government food regulators.
Last week, FDA — in a collaborative effort with the National Association of State Departments of Agriculture, the USDA’s Food Safety and Inspection Service, and the Department of Homeland Security — published a model Food Emergency Response Plan Template. The goal of the response plan is to enhance the protection of the nation’s agricultural industry and food security through prevention, detection, response, and recovery.
The template provides states with a guide to develop either a stand-alone emergency response plan for a food-related emergency or an addendum to an existing all-hazard state emergency response plan. It is a useful planning tool and comes complete with national planning scenarios, target capabilities, and uniform task lists.
Because a food emergency could occur at any point — from farm to table, including pre-harvest production, processing, and distribution — states can use the template to develop useful plans to manage a food emergency. States can design response plans that are similar in structure, scope, and response operations.
Last fall, FDA also published the final rule that requires domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States to register with FDA. The Food Facilities Registration Final Rule, combined with FDA’s other bioterrorism regulations — three of which include 1) Establishment and Maintenance of Records; 2) Administrative Detention; and 3) Prior Notice of Imported Food Shipments — are milestones in food safety and security.
Together, these regulations increase the safety and security of the food supply and better protect Americans from a deliberate act of contamination or an incident of unintentional contamination that could lead to a serious outbreak of food-borne illness.
We must remain vigilant in our mission to protect our country’s food supply as well as to continue our collaborative partnerships, in order to monitor and react to any potential threats. By collaborating more closely with our partners involved in food safety and security, we will be in a better position to leverage available resources to respond to any food emergency incident.
To that end, I have asked Congress to increase our budget for food defense by more than $19 million, in order to expand the network of laboratories that would rapidly and competently analyze samples in the event of a terrorist attack on our nation’s food supply. This cooperative effort, which involves States and several federal agencies, will substantially enhance FDA’s capacity to detect and effectively respond to intentional contamination of our food. As part of this effort, FDA will also expand its program of targeted food defense research.
Food safety remains a real and compelling issue. In the United States we still have 76 million cases of food-borne illness annually. These result in approximately 325,000 hospitalizations and as many as 5,000 deaths each year.
As good stewards in keeping the nation’s food supply safe, we must enact appropriate, science-based, and well-designed measures to minimize or even eliminate food-borne illnesses.
And tonight you are honoring one of those stewards, Dr. Don Zink, by presenting him with the Food Safety Magazine Distinguished Service Award for promoting and advancing science-based solutions for food safety issues. Please allow me a moment here to add my personal congratulations to Don, a Senior Food Scientist at the Center for Food Safety and Applied Nutrition at FDA.
Don is the kind of high-caliber scientist and dedicated professional who continues to make FDA America’s gold standard for safety and security. He brings a unique dedication and distinction to our agency, and it is a special honor that his peers recognize and acknowledge Don’s great work.
American consumers trust the safety of their food. People like Don are a very good reason why.
Fresh-Cut Produce
All of FDA’s people must also keep pace with new and changing tasks. Consider, if you will, the fastest growing segment of the fresh produce industry: fresh-cut produce.
Just last week [3/1/06], FDA published draft guidance for industry that is designed to minimize microbial food safety hazards that are common in the processing of most fresh-cut fruits and vegetables.
Processing produce into fresh-cut produce increases the risk of bacterial contamination and growth, by breaking the natural exterior barrier of the produce through peeling, slicing, coring, trimming, or mashing — with or without washing or other treatment before being packaged for consumption.
Our draft guidance discusses the production and harvesting of fresh produce and provides recommendations for fresh-cut processing in several areas:
(1) personal health and hygiene
(2) training
(3) buildings and equipment
(4) sanitation operations
(5) production and processing controls from product specifications to packaging, storage and transport.
FDA also recommends that processors encourage the adoption of safe practices by their partners throughout the supply chain. We must ensure that any product sold to consumers in a ready-to-eat form is safe. We believe — as I know you do, too — that being aware of the common risk factors and implementing preventive controls will enhance the safety of fresh-cut fruits and vegetables.
Allergens
The safety of our produce clearly affects virtually every American. At the same time, FDA must also address risks on other scales. We must be vigilant about the problem of food allergies, which affect about 2 percent of adults and up to 6 percent of infants and young children in the United States.
With nearly 30,000 consumers requiring emergency room treatment and 150 Americans dying each year because of allergic reactions to food, manufacturers are now required to state in plain English the presence of ingredients that contain protein derived from the eight major allergenic foods: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, or soybeans.
These major food allergens account for 90 percent of all documented IgE-mediated food allergic reactions, some of which may be severe or life-threatening.
We can all agree that every consumer benefits from a more-clearly-labeled product. But we also believe that this labeling will be especially helpful to children who must learn to recognize the presence of substances they must avoid. For example, if a product contains the milk-derived protein, casein [kay-seen], the product's label will have to use the term "milk" in addition to the term "casein" so that those with milk allergies can clearly understand the presence of the allergen they need to avoid.
FDA is not requiring that food manufacturers or retailers re-label or remove from grocery or supermarket shelves products that do not reflect the additional allergen labeling — as long as the products were labeled before January 1, 2006.
We do caution consumers that there will be a transition period of undetermined length during which it is likely that consumers will see packaged food on store shelves and in consumers' homes without the revised allergen labeling.
2005 Food Code
The range of food safety issues — from labeling to allergens and beyond — extends far beyond our family kitchens and neighborhood grocery stores. For that reason, FDA is committed to providing the latest science-based information on food safety for retail and food service industries. Last fall, FDA issued the 2005 Food Code, to be used as a reference by nearly 3,000 regulatory agencies that oversee food safety in restaurants, grocery stores, nursing homes, and other institutional and retail settings.
In collaboration with the Conference for Food Protection, the Centers for Disease Control and Prevention, and U.S. Department of Agriculture, the updated Food Code focuses on enhancing food safety practices, based on new scientific and programmatic information.
It includes not only the best practices for the retail and food service industries, but it also provides valuable resources on food defense that will assist in protecting Americans against threats to the food supply.
Local, state, tribal, and federal regulators voluntarily use the Food Code as a model to develop or update their own food safety rules and to maintain consistency and uniformity with national food regulatory policy. The Association of Food and Drug Officials reported in June 2005, that 48 of 56 States and territories have adopted their own food codes patterned after the FDA’s Food Code. Those 48 states and territories represent 79 percent of the U.S. population.
From the number of states and territories adopting the Food Code, it is evident that keeping food safe for American consumers is a commitment we all take seriously.
Obesity
There is another issue we must take just as seriously: obesity. With almost two-thirds of all adult Americans overweight and over 30 percent obese, we clearly have an urgent public health problem in the United States.
Today, many Federal agencies have programs and initiatives in place to address this problem. While FDA’s involvement does include treatment of weight and obesity through the use of devices and drugs regulated by the agency, our main focus is on prevention, through consumption of an overall healthful diet.
Toward that end, the agency created an Obesity Working Group in August 2003.
In March 2004, that group — the OWG — issued its report, “Calories Count,” which centered on the scientific principle that weight control is a function of caloric balance. The report also outlined a vigorous action plan for FDA to address obesity issues within our regulatory and statutory authority.
The action plan included recommendations to better communicate nutrition information through food labeling, to educate consumers about maintaining a healthy diet and weight, to encourage restaurants and the food industry to provide calorie and nutrition information, and to increase enforcement actions to ensure food labels accurately portray serving sizes.
McDonald’s Corporation took the first step for the quick-service industry in October 2005 when it announced it would begin displaying nutrition information on the majority of its product packaging using an icon and bar chart format, as well as the Nutrition Facts label.
Kraft Foods announced in 2004 that it would provide both single-serving and entire-package nutrition labeling for its snack items containing up to four servings per package.
The Coca Cola Company also has plans to provide dual-column labeling for its 20-ounce sodas, to display information for both the 8-ounce serving and the full 20-ounce container.
We believe — as do the food and restaurant industries — that the fight against overweight and obesity should include the regulation of food labeling as well as the label statements on conventional foods and dietary supplements.
To date, FDA has published two Advanced Notices of Proposed Rulemaking: one on the prominence of calories and the other relating to serving sizes on food labels. We anticipate issuing a third notice on the revision of Daily Values on the nutrition facts panel soon.
Our research-based plans for education initiatives include developing strategies on influencing behavior and promoting healthy eating choices, and developing partnerships in the private and public sectors, including youth-oriented organizations, to give consumers a better understanding of the food label and how to use it to make healthier food choices.
We all recognize that food consumed away from home is an important part of American diets. That’s why we contracted with the Keystone Center to conduct a national dialogue with stakeholders, including public and private decision makers, to explore concrete steps that can be taken to address obesity in the context of away-from-home foods. We expect their report, complete with practical recommendations, in the near future.
FDA has taken steps to enforce the regulations on serving sizes on food labels, by sending 15 letters to manufacturers about inaccurate serving sizes on food labels.
We are also continuing our collaboration with the Federal Trade Commission on false and misleading weight-loss claims, by sending nearly 1,000 letters to manufacturers informing them that FTC has identified weight-loss claims in products that are not scientifically feasible.
And finally, the formation of a second Obesity Working Group continues our focus to ensure that activities related to the “Calories Count” report are being addressed.
Nutrition Education
Promoting health by helping people get better nutrition information about the foods they eat is among FDA's top priorities. The choices Americans make about their diets clearly impact on their well-being.
As people shop for food, they should have — at their fingertips — accurate, helpful, and understandable information about the most important nutritional implications of the products on the shelves. And they should be able to easily fit individual food products into overall healthy diets. People shouldn't need a calculator or an advanced degree in math or nutrition to calculate the components of a healthy meal.
Right now, we communicate some very useful information about the nutritional value of individual foods through nutrition education, and we provide some help in thinking about how foods can contribute to a healthy diet.
To really help consumers understand how food choices contribute to a healthy diet, we should strive to associate food choices both to health consequences and to opportunities to prevent disease.
We need to do more to help consumers effectively channel their interest in healthy foods and healthy diets. Our marketplace should offer a variety of food products that offer significant health benefits, as well as products and diet choices that are described by truthful, non-misleading information. We have to remember that the food label is just one tool we use to inform consumers about their food choices.
Recent Agency Actions
FDA began to meet that challenge when it developed a regulatory strategy for whole grains. Early last month, FDA issued draft guidance that lets manufacturers know what FDA considers appropriate for food label statements related to "whole grain" content. Consumers will now be able to make dietary choices based on a term that is consistent and reliable.
To be specific, we clarified that "whole grain" are cereal grains that consist of the intact, ground, cracked or flaked fruit of the grains whose principal components — the starchy endosperm, germ and bran — are present in the same relative proportions as they exist in the intact grain. Such grains may include barley, buckwheat, bulgur, corn, millet, rice, rye, oats, sorghum, wheat and wild rice.
Consumers should follow the recommendations in the 2005 Dietary Guidelines for Americans, which state that you should eat at least 3 ounces of whole-grain cereals, breads, crackers, rice or pasta every day. One ounce is about 1 slice of bread, 1 cup of breakfast cereal or 1/2 cup of cooked rice or pasta. Consumers should also look to see that grains such as wheat, rice, oats or corn are referred to as "whole" in the list of ingredients.
Barley Claim
In another effort to provide consumers with more information about their food choices, FDA announced an interim final rule that states that 3 grams or more per day of soluble fiber from dehulled and hulless whole grain barley and specific dry-milled barley products may reduce the risk of coronary heart disease.
Coronary Heart Disease — or CHD — is the cause of almost 500,000 deaths annually. Risk factors for CHD include high levels of total cholesterol and low-density lipoprotein, known as LDL or “bad” cholesterol. Scientific evidence tells us that by adding barley to your diet, consumers may lower their risk for CHD as part of a low fat and cholesterol diet.
So, consumers can expect to see whole barley and dry milled barley products such as flakes, grits, flour, meal, and barley meal bearing the health claim.
With the support of the food industry and research conducted by the academic community and others, we must work together to find better ways to empower consumers to make healthier dietary choices — and in a way that is scientifically rigorous.
It is very clear that, as our understanding of disease continues to advance, so will our appreciation for the prominent role that diet plays in promoting health.
In fact, FDA began looking at providing better information to consumers in December 2002, when it initiated the Consumer Health Information for Better Nutrition Task Force Report. The central focus of this initiative was to improve the public availability and consumer understanding of up-to-date scientific evidence on how dietary choices can affect health.
A better-informed public, supported by effective, science-based regulation of health information, would be more likely to make better nutritional choices. In addition, the initiative was designed to encourage producers of conventional foods and dietary supplements to make accurate, up-to-date, science-based claims about the health benefits of their products. This initiative provided for the use of qualified health claims for both conventional human foods and dietary supplements.
In 6 months, the Task Force developed a regulatory framework for qualified health claims in the labeling of conventional human foods and dietary supplements; provided guidance for an interim evidence-based ranking system for scientific data; provided guidance for interim procedures for qualified health claims in the labeling of conventional human food and dietary supplements; and developed a consumer studies research agenda.
As the Task Force Report stated, “claims for which evidence is merely credible would generally not be expected to benefit the public health as much as claims for which the evidence is stronger.” It then becomes clear that FDA takes into account the strength of the evidence supporting the claim.
FDA proceeded to develop interim Guidance documents that gave industry a framework for petitioning for the use of qualified health claims on food labels. Since that time, FDA has responded to numerous qualified health claim petitions and has issued several letters of enforcement discretion.
In addition, we have conducted consumer study research on qualified health claims and will take into consideration consumer studies conducted by outside investigators in consideration for rulemaking.
The results of our own consumer research studies were posted on the web in October. On November 17, 2005, we held a public meeting to gather further comments on the effectiveness of claim language on consumer understanding of the level of science for the claim.
The results of the studies, including our own, that were presented at that meeting indicate that we still have work to do in getting consumers to understand the difference in levels of scientific evidence supporting the relationships between consumption of a food or food component and decreased risk of disease.
We received many thoughtful suggestions at our public meeting, and we will be reviewing those comments, along with consumer study research data, and relevant scientific information to develop a strategy.
In short, we need to continue to work together to find the best way to convey these important messages on conventional food and dietary supplement labels.
We must create a framework for people to get truthful, non-misleading health information about the foods they eat if we are going to take advantage of the opportunity to inspire the use of healthy diets as a means to reduce their risk of chronic disease.
Functional Foods
Part of our responsibility in presenting important health information about the foods we eat requires us to be aware and knowledgeable about trends in foods and their potential impact on our diets.
In fact, FDA has been aware of the growing interest in so-called “functional foods” and has reviewed reports issued by the International Food Information Council, the Institute of Food Technologists, and other professional groups on this issue.
Food choices are important — perhaps critical — in maintaining a healthful lifestyle. In fact, the recent 2005 Dietary Guidelines for Americans outlines diet and lifestyle choices that can help Americans decrease their risk of chronic diseases such as cardiovascular diseases, cancer, and diabetes — and help maintain a healthy body weight.
And now we have functional foods that have been described by professional organizations as “foods and food components that provide a health benefit beyond basic nutrition (for the intended population). Examples may include conventional foods; fortified, enriched or enhanced foods; and dietary supplements.”
It is important to note that dietary supplements should not be categorized as functional foods. The Dietary Supplement Health and Education Act of 1994 specifically excludes from the definition of dietary supplement any product that is “represented for use as a conventional food or as a sole item of a meal or the diet.”
Although FDA does not have a regulatory definition for “functional foods,” there are regulations in place designed to address these products.
A substance added to food is considered a food additive and must be submitted for approval either through the petition or notification process if the substance is not considered Generally Recognized as Safe (GRAS).
Likewise, manufacturers can make claims about a conventional food or a substance in a conventional food, and those claims are health claims, qualified health claims, or structure function claims. However, the manufacturer must provide evidence that supports any statements on the potential benefits of such foods.
And credible evidence is the key. While the regulatory frameworks exist to allow the development of so called “functional foods,” in many cases the critical gap is the scientific evidence to support claim statements on food products.
Since the Task Force on Consumer Health Information for Better Nutrition issued its report, FDA has reviewed 76 proposed claims, but there has been credible evidence to allow enforcement discretion for only 16 claims.
It is appropriate to fortify foods when sufficient information is available to identify a nutritional deficiency and the affected population groups, and the food is suitable to act as a vehicle for the added nutrients.
Closing
I hope the information we have discussed today will help you as you go about the important work of providing safe and nutritious food products to American consumers, and in working with FDA to improve the safety and security of our food supply.
I look forward to continued close collaboration with you in the coming months and years to help achieve our shared goal of a safe and secure global food supply.
Thank you.
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